Priority Substances List - Statement of the Science Report for Ethylene Glycol

1.0 Introduction

The Canadian Environmental Protection Act, 1999 (CEPA 1999) requires the federal Ministers of the Environment and of Health to prepare and publish a Priority Substances List (PSL) that identifies substances, including chemicals, groups of chemicals, effluents and wastes, that may be harmful to the environment or constitute a danger to human health.

Based on initial screening of readily accessible information, the rationale for including ethylene glycol provided by the Ministers' Expert Advisory Panel on the Second Priority Substances List (Ministers' Expert Advisory Panel, 1995) was as follows:

Large volumes of ethylene glycol are used in heat transfer fluids (including automotive antifreeze), aircraft de-icers and in the manufacture of polyesters. Exposure to concentrations that approach those inducing developmental effects in animals may occur through the use of latex paint. The Panel noticed that risk management programs have already been implemented to reduce risks to aquatic ecosystems from the use of de-icing fluids at federally operated airports. An assessment is needed to address potential health concerns from exposure to ethylene glycol in the environment.

The search strategies employed in the identification of data relevant to the characterization of potential effects on the environment (prior to October 1999) and human health (prior to January 2000) are presented in Appendix A. Review articles were consulted where appropriate. However, all original studies that form the basis for this State of the Science Report have been critically evaluated by staff of Environment Canada (entry and environmental exposure and effects) and Health Canada (human exposure and effects on human health).

Preparation of sections of this Report and Supporting Documentation relevant to the environmental part of this report (Environment Canada, 2000) was coordinated and led by M. Lewis of Environment Canada, and an initial draft was prepared by D. Moore and S. Teed of The Cadmus Group Inc. with direct input from the Guidelines and Standards Division of the Ecosystem Science Directorate of Environment Canada. An Environmental Resource Group was established by Environment Canada to assist in the preparation of the environmental characterization. Members were selected based on their expertise and interest in the substance. The assistance and information provided by the Environmental Resource Group members who participated in the preparation and review of this Report and environmental Supporting Document are gratefully acknowledged. These individuals include:

• M. Alaee, Environment Canada
• Y. Bovet, Environment Canada
• D. Bryant, CanTox
• N. Bunce, University of Guelph
• E. Carney, Dow Chemical Company
• G. Grappolini, Petro Canada
• L. Hamel, Union Carbide Canada Inc.
• R. Kent, Environment Canada
• N. Lynch, Environment Canada
• J. Prinsen, Environment Canada
• K. Roberts, Chemical Manufacturers Association
• A. Simpson, Transport Canada
• N. Wesleman, Union Carbide Corporation, USA

Environmental sections of this Report and the environmental Supporting Document were also reviewed by K. Lloyd and P. Doyle from Environment Canada, as well as by external reviewers:

• C. Bertrand, U.S. Environmental Protection Agency
• S. Dobson, Institute of Terrestrial Ecology, U.K.
• J. Dorey, Ontario Ministry of Transportation
• I. Hartwell, Maryland Department of Natural Resources
• D. Maletzki, Beratergremium für Umweltrelevante Altstoffe (BUA), Germany
• D. Pillard, ENSR Consulting and Engineering

The health-related sections of this Report and Supporting Documentation (Health Canada, 2000) were prepared by the following staff of Health Canada:

• R. Beauchamp
• K. Byrne
• R. Gomes
• R.G. Liteplo
• G. Long
• M.E. Meek
• M. Walker

Studies relating to dermal absorption relevant to this Report were reviewed by R. Moody of the Product Safety Bureau of Health Canada. Advice on interpretation of histopathological lesions reported in critical studies was provided by D. Wolf, National Health and Environmental Effects Research Laboratory, U.S. Environmental Protection Agency, and R. Maronpot, U.S. National Institute of Environmental Health Sciences and National Toxicology Program. M. Wade, Environmental and Occupational Toxicology Division of Health Canada, contributed to the interpretation of data on reproductive/developmental toxicity. Statistical support was provided by M. Walker of Health Canada. Sections of the Supporting Documentation pertaining to human health were reviewed externally by the Ethylene Glycol Panel of the Chemical Manufacturers Association, primarily to address adequacy of coverage. Members of the panel included W. Snellings, Union Carbide Corporation, W. Faber, Eastman Kodak, R. Gingell, Shell Chemical Company, and S. Jasti, BASF Corporation.

Accuracy of reporting, adequacy of coverage and defensibility of conclusions with respect to hazard characterization and exposure-response analyses were considered at a panel meeting of the following members, convened by Toxicology Excellence in Risk Assessment (TERA), on February 14, 2000, in Ottawa, Ontario, and during an additional teleconference, held March 29, 2000:

• M.S. Abdel-Rahman, University of Medicine and Dentistry of New Jersey
• C. Abernathy, Office of Water, U.S. Environmental Protection Agency
• J.P. Christopher, California Environmental Protection Agency
• J.C. Collins, Solutia, Inc.
• J.T. Colman, Syracuse Research Corporation
• M. Mumtaz, Agency for Toxic Substances and Disease Registry K.A. Poirier, TERA
• J.E. Whalan, U.S. Environmental Protection Agency

R. Maronpot, U.S. National Institute of Environmental Health Sciences and National Toxicology Program, and E. Ohanian, Office of Water, U.S. Environmental Protection Agency, provided advice on adequacy of histopathological reporting in one of the critical studies during the teleconference.

The health-related sections of this Report were reviewed and approved by the Health Protection Branch Risk Management meeting of Health Canada

The entire State of the Science Report was reviewed and approved by the Environment Canada/Health Canada CEPA Management Committee.

The text of the Report has been structured to address environmental effects initially, followed by effects on human health.